FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

ENvizion’s Feeding Tube Placement Device Cleared

April 3, 2019
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ENvizion’s ENvue electromagnetic feeding tube placement (EFTP) system gained 510(k) clearance from the FDA to address injuries caused by tube misplacement.

The device, which is applied at a patient’s bedside, is designed for the precise positioning of feeding tubes into the GI tract to safely avoid the patient’s lungs.

More than six million feeding tubes are inserted per year in the U.S. and more than a million are misplaced, leading to injury and even death, the company said.

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